Policosanol is a cholesterol-lowering natural mixture of primary alcohols, isolated and purified from sugar cane wax. Policosanol is safe and well tolerated, even in populations with high use of concomitant medications.

Lipid profile improvements with the use of policosanol are seen in healthy volunteers, patients with type II hypercholesterolemia (high cholesterol), type 2 diabetics with hypercholesterolemia, postmenopausal women with hypercholesterolemia, and patients with combined hypercholesterolemia and abnormal liver function tests. However, there is controversy in this are based on recent negative evidence.

Policosanol has performed equal to or better than simvastatin, pravastatin, lovastatin, probucol, or acipimox with fewer side effects in patients with type II hypercholesterolemia.

Policosanol was approved for use in Cuba in 1991. Currently it is used in more than 25 countries throughout the world, mainly in South America and in the Caribbean region.

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

GRADE *

Various studies have investigated the effect of policosanol on platelet aggregation. In general, studies suggest policosanol inhibits platelet aggregation induced by collagen and arachidonic acid.

A

The effects of policosanol supplementation on exercise-ECG testing responses have been studied in individuals with coronary heart disease (CHD). Beneficial changes were noted in functional capacity, rest and exercise angina (chest pain), cardiac events and maximum oxygen uptake. Although this represents early compelling evidence, further research is necessary before a clear conclusion can be reached.

B

There is limited study of the effects of policosanol supplementation on walking distance in individuals with intermittent claudication. Additional human trials are necessary before a strong recommendation can be made.

B

Policosanol has been used and recommended to treat high cholesterol (hypercholesterolemia). Many studies have tested the effects of policosanol on cholesterol levels, and have found benefits. However, some newer research suggests that policosanol may not be as beneficial as previously thought.

C

The effects of policosanol supplementation on reactivity and related brain activity have been examined. Although there is early compelling evidence, further research is necessary before a clear conclusion can be reached.

C

* Key to grades

A: Strong scientific evidence for this useB: Good scientific evidence for this useC: Unclear scientific evidence for this useD: Fair scientific evidence for this use (it may not work)F: Strong scientific evidence against this use (it likley does not work)

Tradition / Theory
The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.

Typical doses of policosanol are between 5-40 milligrams daily. Policosanol appears safe in these doses for up to three years. Based on the available evidence, this dose range is considered safe and effective in patients with coronary heart disease and for patients with type II hypercholesterolemia (high cholesterol). Doses as high as 80 grams of policosanol have been taken daily for 12 weeks to treat high cholesterol. For platelet aggregation, 10-40 milligrams daily has been taken. For intermittent claudication, 10-20 milligrams has been used, and for hypertension (high blood pressure), a lower dose of 5-10 milligrams daily has been taken.

Children (younger than 18 years)

There is no proven safe or effective dose for policosanol in children.

Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid in individuals with a known allergy or hypersensitivity to policosanol.

Side Effects and Warnings

Policosanol is generally regarded as safe and well tolerated. However, there are a few, minor drug-related clinical or biochemical adverse effects observed in clinical trials. Frequency of mild, moderate and serious adverse events, as well a death rate, has been shown to be lower in diabetic and non-diabetic individuals taking policosanol compared with placebo.

Policosanol may cause erythema (reddening of the skin), gum bleeding, headache, vertigo, or heartburn. Use cautiously in patients taking aspirin due to potential additive platelet inhibition and risk of bleeding. Also use caution in patients with high blood pressure or those taking agents to lower blood pressure due to a potential additive effect. Side effects of Octa-60g (a combination product including policosanol) may include skin rash, and increased glucose and alanine aminotransferase.

Pregnancy and Breastfeeding

Policosanol is not recommended in pregnant or breastfeeding women due to a lack of available scientific evidence. Although not well studied in humans, policosanol does not appear to affect reproductive performance, fetal/neonatal development, or breastfeeding. Additional study is needed in this area.

In theory, policosanol may interact additively with nicotinic acid (Acipimox®) or synthetic nicotinic acid due to Acipimox®'s cholesterol-lowering activity. Caution is advised in patients taking other cholesterol-lowering agents. In theory, bile acid sequestrants/resins, ezetimibe (Zetia®), or statins (lovastatin, atorvastatin, simvastatin, pravastatin) may have an additive cholesterol-lowering effect when given with policosanol.

Policosanol may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anti-platelet drugs such as clopidogrel (Plavix®), and non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®). The addition of policosanol to warfarin therapy did not enhance the prolongation of the bleeding time induced by warfarin alone.

Policosanol may decrease arterial pressure, and thus may have additive effects with beta-blockers, or other blood pressure-lowering agents. Medication adjustments may be necessary.

Although not well studied in humans, the activity of nifedipine remained unchanged in animals treated with a high dose policosanol. There is no information regarding potential interaction with other calcium channel blockers.

Because policosanol possesses an antioxidant effect and nitric oxide can be destroyed by oxygen-derived radicals, there is a theoretical interaction between policosanol and nitroprusside and other nitrates. Consult with a qualified healthcare professional, including a pharmacist, to check for any interactions.

In theory, taking ticlopidine and policosanol together may cause an additive interaction.

Although not well studied in humans, policosanol may also interact with agents broken down by the liver, or agents taken for Alzheimer's disease, cardiovascular disorders, diabetes or neurologic disorders.

Interactions with Herbs and Dietary Supplements

In theory, there may be an additive hypotensive (blood pressure lowering) effect when policosanol is used with herbs that lower blood pressure.

Concurrent therapy with policosanol and omega-3 fatty acids may have an additive lowering effect on the lipid profile and platelet aggregation. Caution is advised.

Although not well studied in humans, policosanol may also interact with herbs and supplements broken down by the liver, or herbs and supplements taken for Alzheimer's disease, cardiovascular disorders, diabetes or neurologic disorders.

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.